Label: CODENATURE VIAMI TONE UP SHIELD CREAM- ethylhexyl methoxycinnamate, titanium dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 20, 2020

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  • Active Ingredients

    Ethylhexyl Methoxycinnamate 6.8%

    Titanium Dioxide (CI 77891) 3.95%

    Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 2.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert : Spending time in the sun increases your

    Risk of skin cancer and early skin aging. This product has been shown

    Only to prevent sunburn, no skin cancer or early skin aging.

    For external use only

  • Do not use

    on damaged or broken skin

  • When using this product

    keep out of eyes

  • Stop use and ask a doctor

    if rash occurs

  • Keep out of reach of children.

    If product is swallowed, get medical

    Help or contact a poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure

    Reapply:

    - After 40 minutes of swimming or sweating

    - Immediately after towel drying

    - At least every 2 hours

    Children under 6 months : Ask a doctor

  • Inactive Ingredients

    Glycerin, Dipropylene Glycol, Phenethyl Benzoate, Terephthalylidene Dicamphor Sulfonic Acid,

    Dimethicone, Dicaprylyl Carbonate, Alcohol Denat, Niacinamide, Tromethamine, Caprylyl Methicone

    Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Potassium Cetyl Phosphate,

    Glyceryl Stearate, PEG-100 Stearate, Isohexadecane, Cetyl Alcohol, Sorbitan Sesquioleate, Silica,

    Camellia Sinensis Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Water

  • Other Information

    Protect this product from excessive heat and direct sun

  • Package Label

    30ml NDC: 78625-201-01 Label

  • INGREDIENTS AND APPEARANCE
    CODENATURE VIAMI TONE UP SHIELD CREAM 
    ethylhexyl methoxycinnamate, titanium dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78625-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6800 mg  in 100 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL2500 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3950 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)  
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    ECAMSULE (UNII: M94R1PM439)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALCOHOL (UNII: 3K9958V90M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78625-201-0130 mL in 1 TUBE; Type 0: Not a Combination Product06/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/20/2020
    Labeler - CODENATURE INC (690242086)
    Registrant - CODENATURE INC (690242086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(78625-201)
    Establishment
    NameAddressID/FEIBusiness Operations
    CODENATURE INC690242086label(78625-201)
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